Design and Development of a Fully Intelligent Nursing Information System Based on International Standard Nursing Terminology.

OBJECTIVE: Design and develop a Clinical Care Classification (CCC) nursing information system aligned with nursing terminology CCC, emphasizing standard procedures and a responsibility-based nursing model to enhance efficiency and quality of care. METHODS: Conduct thorough investigation into clinical nursing informatics needs, analyze existing system shortcomings, utilize Microsoft.net for development, integrate standard nursing procedures and clinical operating protocols into system functions. Structure database based on bed characteristics, implant CCC Nursing Terminology and clinical nursing knowledge base. RESULTS: Successfully design and develop CCC Nursing Information System featuring patient list, nurse assignment, nursing evaluation, diagnosis, goals, plan, interventions, special care, shift handover, record query, workload statistics, and intelligent guidance based on patient assessment and nursing elements. CONCLUSION: The CCC Nursing Information System advances standard nursing procedures in clinical practice, promoting standardization and responsibility-based holistic care. It harnesses big data to enhance system intelligence.

Drugs that act in the lymphatic system and lymphatic drug delivery: review and perspective / 药学学报

The lymphatic system, as well as pathological changes of the lymphatic system, underlies the progress of an array of diseases and conditions, including cancer, inflammation and autoimmune disorders, infectious diseases and metabolic syndrome. A variety of biological targets in the lymphatic system can be employed to modulate these high-burden diseases, and the pharmacokinetics and drug delivery strategies in the context of lymphatics are of critical importance to optimise drug exposure to lymphatic-related targets. As such, research and drug development in this field has gained increasing attention in recent years. This article aims to provide an overview of pharmaceutical research with a focus on the lymphatic system and therapeutic targets within the lymphatics, followed by lymphatic drug delivery approaches, which may be of interest for researchers in academia, pharmaceutical industry and regulatory sciences.

Efficacy and safety of artificial liver support therapy with a selective plasma separator in low-platelet count patients with acute-on-chronic liver failure / 临床肝胆病杂志

ObjectiveTo investigate the efficacy and safety of artificial liver support therapy with an Evanure-4A selective membrane plasma separator and its influence on platelet count in the treatment of patients with acute-on-chronic liver failure （ACLF） patients with different platelet counts. MethodsA total of 302 patients with ACLF who were hospitalized in Department of Hepatology， Chengdu Public Health Clinical Medical Center， from January 2021 to May 2023， were enrolled， and according to the platelet count （PLT）， they were divided into group A （25×109/L — 50×109/L） with 101 patients， group B （51×109/L — 80×109/L） with 98 patients， and group C （81×109/L — 100×109/L） with 103 patients. In addition to medical treatment， all patients received different modes of artificial liver support therapy based on their conditions， including plasma perfusion combined with plasma exchange， double plasma molecular adsorption combined with plasma exchange， and bilirubin system adsorption combined with plasma exchange. The paired t-test was used for comparison of continuous data before and after treatment in each group； an analysis of variance was used for comparison between multiple groups， and the SNK-q test was used for further comparison between two groups； the chi-square test was used for comparison of categorical data between multiple groups. ResultsOf all 302 patients， 268 （88.74%） achieved varying degrees of improvement in clinical symptoms after artificial liver support therapy. After treatment， all three groups had varying degrees of reductions in alanine aminotransferase （t=14.755， 21.614， and 15.965， all P<0.001）， aspartate aminotransferase （t=11.491， 19.301， and 13.919， all P<0.001）， total bilirubin （t=19.182， 17.486， and 21.75， all P<0.001）， and international normalized ratio （INR） （t=3.497， 3.327， and 4.358， all P<0.05）. After artificial liver support therapy with an Evanure-4A selective membrane plasma separator， PLT in group A decreased from （37.73±6.27）×109/L before treatment to （36.59±7.96）×109/L after treatment， PLT in group B decreased from （66.97±7.64）×109/L before treatment to （62.59±7.37）×109/L after treatment， and PLT in group C decreased from （93.82±5.38）×109/L before treatment to （85.99±12.49）×109/L after treatment； groups B and C had significant reductions in PLT after treatment （t=12.993 and 8.240， both P<0.001）， but there was no significant difference in group A （P>0.05）. There was no significant difference in the incidence rate of adverse reactions during artificial liver support therapy between the three groups （P>0.05）. ConclusionArtificial liver support therapy can improve liver function and INR in patients with ACLF. The use of Evaure-4A selective membrane plasma separator during artificial liver support therapy has little influence on platelets， and it is safe in the treatment of ACLF patients with a significantly lower level of platelets.

Establishment of a Method for Galvanic Vestibular Stimulation-vestibular Evoked Myogenic Potentials in Healthy Children / 听力学及言语疾病杂志

Objective To establish the methods of galvanic vestibular stimulation-vestibular evoked myogenic potentials(GVS-VEMPs)in healthy children and to obtain the normal value of GVS-cVEMP and GVS-oVEMP in these children in China.Methods Twenty(3～14 years)healthy children and 24 healthy adults(18～30 years)were enrolled for conventional examinations of GVS-cVEMP and GVS-oVEMP.Using the galvanic stimulation in-tensity under 3 mA/1 ms for children and 5 mA/1 ms for adults.The characteristics of elicitation and parameter re-sults of GVS-cVEMP and GVS-oVEMP in children and adults,as well as the pain scores and the elicitation of differ-ent stimulus intensities in the two age groups were recorded.Results The elicitation of GVS-cVEMP and GVS-oVEMP were both 100.0％in children and adult groups.The p1 latency,n1 latency and p1-n1 interval latency of GVS-cVEMP were 10.46±1.84 ms,16.98±2.12 ms and 6.52±1.42 ms respectively in children group,the n1 la-tency and p1-n1 interval latency were significantly shorter than the adult group(P＜0.05).The n1 latency,p1 la-tency and p1-n1 interval latency of GVS-oVEMP were 8.87±1.40 ms,12.25±1.80 ms and 3.39±1.07 ms re-spectively in children group with no significant difference between the two groups.The thresholds of GVS-cVEMP and GVS-oVEMP in children group were significantly lower than adult group(P＜0.01),but no differences were found in adult group regarding on the amplitude and interaural amplitude asymmetry ratio.In addition,with the in-crease of the intensity of galvanic stimulation,the correlation between pain scores and the elicitation rates of GVS-cVEMP and GVS-oVEMP also increased.Conclusion Using appropriate stimulus intensity and recording methods,GVS-cVEMP and GVS-oVEMP could be successfully assessed and detected in healthy children over 3 years old and adolescents.The latency of GVS-cVEMP in children is slightly shorter than that in adults,therefore we recommend selecting the matched age group for assessment in the children group.

Efficacy and safety of budesonide combined with pulmonary surfactant in the treatment of neonatal meconium aspiration syndrome:a systematic review / 药物流行病学杂志

Objective To evaluate the efficacy and safety of budesonide combined with pulmonary surfactant(PS)in the treatment of meconium aspiration syndrome(MAS)in neonates.Methods PubMed,Cochrane Central Register of Controlled Trials(Central),Embase,Web of Science,SinoMed,VIP,WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials(RCTs)of budesonide combined with PS in the treatment of neonatal MAS from inception to September 2,2023.Two researchers independently screened literature,extracted data and assessed the risk of bias of the included studies,meta-analyses were performed by using the RevMan 5.4 software.Results A total of 6 RCTs involving 544 patients were included.The results of meta-analysis showed that compared with PS group,budesonide combined with PS group had higher overall effective rate(RR=1.29,95％CI 1.17 to 1.41,P＜0.001),shorter hospital stay(MD=-6.35,95％CI-9.25 to-3.46,P＜0.001)and shorter time of oxygen inhalation(MD=-1.61,95％CI-2.23 to-0.98,P＜0.001),shorter the duration of ventilator use(MD=-26.46,95％CI-35.98 to-16.95,P＜0.001),improved the blood gas analysis indexes at each time after treatment(P＜0.05);In terms of safety,the incidence of total complications and adverse reactions in budesonide combined with PS group was significantly lower(RR=0.35,95％CI 0.25 to 0.47,P＜0.001).Subgroup analysis showed that the incidence of persistent pulmonary hypertension of the newborn(PPHN)in the budesonide combined with PS group was decreased(RR=0.38,95％CI 0.19 to 0.74,P=0.004),and the incidence of pneumorrhagia was decreased(RR=0.26,95％CI 0.10 to 0.69,P=0.007),and the difference was statistically significant;the incidence of heart failure and sepsis was not statistically significant compared with the PS group(P＞0.05).Conclusion Current evidence shows that budesonide combined with PS in the treatment of neonatal meconium aspiration syndrome can improve the symptoms and signs of MAS children,improve the blood gas analysis index,accelerate disease rehabilitation,shorten the course of the disease,can help reduce the risk of complications and PPHN,pneumorrhagia,and doesn't increase the incidence of heart failure,sepsis.Due to the limited quantity of the included studies,more high-quality and large-sample RCTs are needed to further validate the above conclusions.

Online trace detection of mercury ions with enhanced fluorescence excitation within metal-lined hollow-core fiber.

In this Letter, we present a portable all-fiber fluorescent detection system based on metal-lined hollow-core fiber (MLHCF) for the ultra-sensitive real-time monitoring of mercury ions (Hg2+). The system employs a rhodamine derivative as the probe. The hollow core of the MLHCF serves as both the flow channel of the liquid sample and the waveguide of the optical path. The metal coating in the intermediate layer between the capillary and the polyimide (PI) coating in the MLHCF provides good light confinement, enhancing the interaction between the sample and the incident light for better fluorescence excitation and collection efficiency. Additionally, further enhancement is achieved by placing an inserted filter along the light path to reflect the excitation light back to the MLHCF. A 3-cm length of MLHCF enables simultaneous excitation of a 40-µL sample volume and collection of most of its fluorescent signal in all directions, thereby significantly contributing to its exceptional sensitivity with a limit of detection (LOD) of 2.3 ng/L. The all-fiber fluorescence-enhanced detection device also shows rapid response time, excellent reusability, and selectivity. This system presents an online, reproducible, and portable solution for the trace detection of Hg2+ and provides a promising way for detecting other heavy metal ions.

Plurihormonal PIT1-lineage pituitary neuroendocrine tumors: a clinicopathological study / 中华病理学杂志

Objective: To investigate the clinicopathological characteristics of plurihormonal PIT1-lineage pituitary neuroendocrine tumors. Methods: Forty-eight plurihormonal PIT1-lineage tumors were collected between January 2018 and April 2022 from the pathological database of Sanbo Brain Hospital, Capital Medical University. The related clinical and imaging data were retrieved. H&E, immunohistochemical and special stains were performed. Results: Out of the 48 plurihormonal PIT1-lineage tumors included, 13 cases were mature PIT1-lineage tumors and 35 cases were immature PIT1-lineage tumors. There were some obvious clinicopathological differences between the two groups. Clinically, the mature plurihormonal PIT1-lineage tumor mostly had endocrine symptoms due to increased hormone production, while a small number of immature PIT1-lineage tumors had endocrine symptoms accompanied by low-level increased serum pituitary hormone; patients with the immature PIT1-lineage tumors were younger than the mature PIT1-lineage tumors; the immature PIT1-lineage tumors were larger in size and more likely invasive in imaging. Histopathologically, the mature PIT1-lineage tumors were composed of large eosinophilic cells with high proportion of growth hormone expression, while the immature PIT1-lineage tumors consisted of chromophobe cells with a relatively higher expression of prolactin; the mature PIT1-lineage tumors had consistently diffuse cytoplasmic positive staining for keratin, while the immature PIT1-lineage tumors had various expression for keratin; the immature PIT1-lineage tumors showed more mitotic figures and higher Ki-67 proliferation index; in addition, 25.0% (12/48) of PIT1-positive plurihormonal tumors showed abnormal positive staining for gonadotropin hormones. There was no significant difference in the progression-free survival between the two groups (P=0.648) by Kaplan-Meier analysis. Conclusions: Plurihormonal PIT1-lineage tumor belongs to a rare type of PIT1-lineage pituitary neuroendocrine tumors, most of which are of immature lineage. Clinically increased symptoms owing to pituitary hormone secretion, histopathologically increased number of eosinophilic tumor cells with high proportion of growth hormone expression, diffusely cytoplasmic keratin staining and low proliferative activity can help differentiate the mature plurihormonal PIT1-lineage tumors from the immature PIT1-lineage tumors. The immature PIT1-lineage tumors have more complicated clinicopathological characteristics.

Application of ARIMA model in predicting pediatric red blood cell usage / 中国输血杂志

【Objective】 To explore the feasibility of using autoregressive moving average model (ARIMA) to predict the dosage of suspended red blood cells in children, and to provide a basis for the development of clinical blood reserve plans in children's hospitals. 【Methods】 ARIMA model was constructed using the total blood consumption of clinical suspended red blood cells from March 2016 to May 2022 at the Children's Hospital of Chongqing Medical University as the data source by SPSS26.0 software. The optimal model was used to predict the clinical suspended red blood cell consumption from June to October 2022, and the predictive effect of the model was tested. 【Results】 ARIMA(0, 1, 1) (0, 1, 1)12 was the optimal model for predicting the consumption of suspended red blood cells in pediatrics. The autocorrelation function and partial autocorrelation function of the residual sequence basically fell within the 95% confidence interval. At the same time, Ljung-Box Q statistical results showed that there was no correlation between the residual (P>0.05), indicating that the residual was white noise, which met the randomicity hypothesis. The average relative error between the predicted values of the model and the actual clinical red blood cell usage from June to October 2022 was 5%, indicating high prediction accuracy. 【Conclusion】 The blood usage of children has obvious seasonal and periodic patterns, and the optimal model ARIMA (0, 1, 1) (0, 1, 1)12 can better fit the trend of changes in pediatric suspended red blood cell usage, thus providing a basis for the development of clinical blood reserve plans in children's hospitals.

PRE-084 ameliorated learning and memory impairment in T1DM via regulating neuronal MAM / 西安交通大学学报(医学版)

【Objective】 Diabetic mice could show learning and memory dysfunction, and we aimed to investigate the effect of Sigma-1 receptor agonist, PRE-084, on neurons and cognitive impairment in mice with type 1 diabetes (T1DM). 【Methods】 Twenty mice with T1DM induced by streptozocin, aged 8-10 weeks, and 20 control mice (CON) were randomly divided into four groups (CON+Vehicle, CON+PRE-084, T1DM+Vehicle and T1DM+PRE-084). Mouse primary neurons were cultured in high glucose medium with PRE-084 and control solvent, respectively. The body weight, food and water intake, and fasting blood glucose level of mice in each group were detected and recorded. The learning and memory abilities of mice were detected by new object recognition experiment. The mitochondria-associated endoplasmic reticulum membrane (MAM) structure of neurons in hippocampal CA1 area of mice was detected by transmission electron microscope. And the expression levels of ATP and reactive oxygen species (ROS) in hippocampus of mice were detected by biochemical kit. Cell viability and ROS level of primary neurons were detected by CCK8 and cellular ROS kit. 【Results】 PRE-084 reduced the increase of body weight, food and water intake, and blood glucose caused by diabetes. PRE-084 significantly ameliorated the learning and memory impairment of the mice with T1DM, improved the changes of MAM structure in neurons of hippocampal CA1 area of diabetic mice, increased the level of ATP in hippocampus of diabetic mice, and decreased the increase of ROS expression in diabetic hippocampus and neurons under high glucose conditions. 【Conclusion】 Sigma-1 receptor agonist, PRE-084, could improve learning and memory impairment in the mice with T1DM, which might be related to the structural changes of MAM, the increase of ATP production, and the decrease of ROS production in hippocampal neurons.

KHK involved in intestinal barrier impairment by high-fat and high-fructose diet / 西安交通大学学报(医学版)

【Objective】 To explore the effect of high-fat and high-fructose diet on mouse intestinal barrier function, as well as the role of ketohexokinase (KHK), the key enzyme in fructose metabolism, in intestinal barrier impairment. 【Methods】 Eight-week-old male control C57BL/6J mice and Khk-/- mice were randomly divided into control + normal diet (ND), control + high-fat and high-fructose diet (HFHFD), Khk-/-+ normal diet (ND+Khk-/-), and Khk-/-+ high-fat and high-fructose diet (HFHFD+Khk-/-) groups, with eight mice in each group. During the high-fat and high-fructose diet and normal diet, the body weight changes of mice in different groups were recorded. After the intervention, the blood glucose and insulin levels of mice in each group were detected. The intestinal barrier function and inflammation level of mice were evaluated by detecting intestinal water content, permeability, tight junction protein expression, serum and intestinal inflammatory factor levels. 【Results】 Compared with ND group, HFHFD group significantly increased the body weight, blood glucose and insulin levels of mice, increased the intestinal water content and permeability, decreased the expression of tight junction proteins, and increased inflammatory factors of the serum and intestines. In the two groups fed with high-fat and high-fructose diet, the body weight, blood glucose and insulin levels of the HFHFD+Khk-/- group were significantly lower than those of HFHFD group, and the intestinal barrier dysfunction and inflammation were significantly improved. 【Conclusion】 KHK, a key enzyme in fructose metabolism, is involved in the impairment of intestinal barrier caused by high-fat and high-fructose diet. Knockout of Khk gene significantly improved intestinal barrier dysfunction and the inflammation level.

The mechanism of cilostazole alleviating intestinal mucosal barrier dysfunction in type 2 diabetic mice / 西安交通大学学报(医学版)

【Objective】 To explore the effect of cilostazol on intestinal barrier function in type 2 diabetes (T2DM). 【Methods】 The GSE142153 dataset was downloaded from GEO database to analyze gene changes in diabetic patients. Eight-week-old male db/db mice and control m/m mice were randomly divided into m/m+cmc, m/m+cilo, db/db+cmc, and db/db+cilo groups. Mice in different groups were given cilostazol and corresponding solvents for 4 weeks. We detected the levels of serum sCD40L and the expression of CD40 in intestinal tissue, and evaluated the mice’s intestinal barrier function by examining intestinal permeability, water content, bacterial number, and tight junction protein expression in different groups. 【Results】 Differential expressed genes were enriched in platelet activation and endothelial barrier function pathways in diabetic patients. Compared with those in the control group, the levels of serum sCD40L in db/db diabetic mice elevated significantly, and the CD40 expression, permeability, water content and bacterial number in intestinal tissue increased obviously, while the expression of tight junction protein decreased. Cilostazol treatment in diabetic mice decreased the levels of serum sCD40L and CD40, and alleviated significantly the intestinal barrier dysfunction. 【Conclusion】 Cilostazol attenuated the damage of intestinal barrier function in T2DM, and its protective effect may be related to the inhibition of platelet activation in diabetic mice.

Positive Association of TEAD1 With Schizophrenia in a Northeast Chinese Han Population

Objective@#Schizophrenia is a complex and devastating psychiatric disorder with a strong genetic background. However, much uncertainty still exists about the role of genetic susceptibility in the pathophysiology of schizophrenia. TEA domain transcription factor 1 (TEAD1) is a transcription factor associated with neurodevelopment and has modulating effects on various nervous system diseases. In the current study, we performed a case–control association study in a Northeast Chinese Han population to explore the characteristics of pathogenic TEAD1 polymorphisms and potential association with schizophrenia. @*Methods@#We recruited a total of 721 schizophrenia patients and 1,195 healthy controls in this study. The 9 single nucleotide polymorphisms (SNPs) in the gene region of TEAD1 were selected and genotyped. @*Results@#The genetic association analyses showed that five SNPs (rs12289262, rs6485989, rs4415740, rs7113256, and rs1866709) were significantly different between schizophrenia patients and healthy controls in allele or/and genotype frequencies. After Bonferroni correction, the association of three SNPs (rs4415740, rs7113256, and rs1866709) with schizophrenia were still evident. Haplotype analysis revealed that two strong linkage disequilibrium blocks (rs6485989-rs4415740-rs7113256 and rs16911710-rs12364619-rs1866709) were globally associated with schizophrenia. Four haplotypes (C-C-C and T-T-T, rs6485989-rs4415740-rs7113256; G-T-A and G-T-G, rs16911710-rs12364619-rs1866709) were significantly different between schizophrenia patients and healthy controls. @*Conclusion@#The current findings indicated that the human TEAD1 gene has a genetic association with schizophrenia in the Chinese Han population and may act as a susceptibility gene for schizophrenia.

Effective constituents of essential oil from Gleditsiae Fructus Abnormalis and anti-cerebral ischemia/reperfusion injury mechanism: based on GC-MS, network pharmacology, and experimental verification / 中国中药杂志

Based on GC-MS and network pharmacology, the active constituents, potential targets, and mechanism of essential oil from Gleditsiae Fructus Abnormalis(EOGFA) against cerebral ischemia/reperfusion(I/R) injury were explored, and the effective constituents were verified by experiment. To be specific, GC-MS was used identify the constituents of the volatile oil. Secondly, the targets of the constituents and disease were predicted by network pharmacology, and the drug-constituent-target network was constructed, followed by Gene Ontology(GO) term enrichment and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment of the core targets. Molecular docking was performed to investigate the binding affinity between the active constituents and the targets. Finally, SD rats were used for experimental verification. The I/R injury model was established, and the neurological behavior score, infarct volume, and pathological morphology of brain tissue were measured in each group. The content of interleukin-1β(IL-1β), interleukin-6(IL-6), and tumor necrosis factor-alpha(TNF-α) was determined by enzyme-linked immunosorbent assay(ELISA), and the protein expression of vascular endothelial growth factor(VEGF) by Western blot. A total of 22 active constituents and 17 core targets were screened out. The core targets were involved in 56 GO terms and the major KEGG pathways of TNF signaling pathway, VEGF signaling pathway, and sphingolipid signaling pathway. Molecular docking showed that the active constituents had high affinity to the targets. The results of animal experiment suggested that EOGFA can alleviate the neurological impairment, decrease the cerebral infarct volume and the content of IL-1β, IL-6 and TNF-α, and down-regulate the expression of VEGF. The experiment verified the part results of network pharmacology. This study reflects the multi-component, multi-target, and multi-pathway characteristics of EOGFA. The mechanism of its active constituents is related to TNF and VEGF pathways, which provides a new direction for in-depth research on and secondary development of Gleditsiae Fructus Abnormalis.

Protective effect of Yougui Yin on steroid-induced avascular necrosis of femoral head in rats by regulating the Wnt/β-catenin signaling pathway / 国际中医中药杂志

Objective:To investigate the effect of Yougui Yin on steroid-induced femoral head necrosis in rats and the regulation of Wnt/β-catenin signaling pathway, and to explore its mechanism.Methods:Fifty SD rats were randomly divided into normal group, model group, high-dose group (26.4 g/kg), medium-dose group (13.2 g/kg) and low-dose group (6.6 g/kg) of Yougui Yin, with 10 rats in each group. Except the normal group, the other groups were prepared with SANFH model by combining LPS and methylprednisolone injection. The treatment groups were intragastrically administered with Yougui Yin, once a day for 8 weeks. After the final administration, the serum calcium and phosphorus levels of rats in each group were determined by automatic biochemical analyzer. The femoral head specimens of rats in each group were detected by MRI, and the pathological changes of the femoral head were observed by HE staining. The expressions of caspase-3, β-catenin and Wnt3α mRNA in the femoral head of rats were detected by RT-PCR.Results:Compared with the model group, the levels of serum calcium and phosphorus in the medium and high dose groups were increased significantly ( P<0.05, P<0.01), and the level of serum phosphorus in the low dose group was increased significantly ( P<0.05); In the medium and high dose groups, the femoral empty bone lacuna rate was decreased ( P<0.05, P<0.01); The expression of caspase-3 mRNA (2.146±0.191, 1.688±0.247, 1.370±0.252 vs. 2.535±0.236) in the low, medium and high dose groups were decreased ( P<0.05, P<0.01), and the expression of β-catenin mRNA (0.433±0.102, 0.496±0.091, 0.698±0.089 vs. 0.259±0.106) were increased ( P<0.05, P<0.01); The expression of Wnt3α mRNA (0.509±0.061, 0.833±0.053 vs. 0.384±0.052) in the medium and high dose groups were increased ( P<0.05, P<0.01); In the medium and high dose groups, MRI showed higher T2 signals around the joint, and high T2 signals within the joint, which were clearly distinguished from the femoral head cartilage, and there was no obvious abnormal signal within the femoral head. HE staining in the Yougui Yin medium and high dose groups showed that trabecular bone was coarse and arranged regularly, most of the bone cells were normal, and empty bone lacunae were less. Conclusion:The protective effect of Yougui Yin on SANFH rats may be related to the inhibition of Wnt/β-catenin signaling pathway.

Rethinking the marketing strategy of anti-tumor drugs by single-arm trials supported / 中华肿瘤杂志

Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.

Pediatric SMARCB1/INI1-deficient poorly differentiated chordoma of the skull base: report of five cases and review of literature / 中华病理学杂志

Objective: To investigate the clinicopathological characteristics and differential diagnosis of pediatric SMARCB1/INI1-deficient poorly differentiated chordoma (PDC) of the skull base. Methods: Five cases of SMARCB1/INI1-deficient PDC were identified in 139 cases of chordoma diagnosed in Sanbo Brain Institute, Capital Medical University, Beijing, China from March 2017 to March 2021. The clinical and imaging data of the 5 PDCs were collected. H&E and immunohistochemical staining, and DNA methylation array were used, and the relevant literatures were reviewed. Results: All 5 PDCs were located at the clivus. The average age of the patients was 6.4 years, ranging from 3 to 16 years. Three patients were female and two were male. Morphologically, in contrast with classical chordomas, they presented as epithelioid or spindle tumor cells organized in sheets or nests, with necrosis, active mitoses, and infiltration into surrounding tissue. All cases showed positivity of CKpan, EMA, vimentin and brachyury (nuclear stain), and loss of nuclear SMARCB1/INI1 expression. S-100 protein expression was not frequent (2/5). Ki-67 proliferative index was high (20%-50%). All cases had over-expressed p53. It was necessary to differentiate SMARCB1/INI1-dificient PDC from SMARCB1/INI1-dificient tumors occurring at skull base of children or the tumors with epithelial and spindle cell morphological features. The 3 PDCs with DNA methylation testing showed the methylation profiles different from the pediatric atypical teratoid/rhabdoid tumors. They formed an independent methylation profile cluster. The clinical prognosis of the 5 patients was poor, and the overall survival time was 2-17 months. Conclusions: PDC is a special subtype of chordoma, which often affects children and occurs in the clivus. The PDC shares epithelioid or spindle cell morphologic features which are different from the classic chordoma. Besides the typical immunohistochemical profile of chordoma, PDC also has loss of nuclear SMARCB1/INI1 expression and distinct epigenetic characteristics.

Design and Development of Cloud Platform of Emergency COVID-19 Nucleic Acid Detection / 中国医疗器械杂志

According to the characteristics of short time and large amount of samples for out of hospital emergency nucleic acid detection, this study introduces an out of hospital emergency nucleic acid detection cloud platform system, which realizes the functions of rapid identification of the detected person and one-to-one correspondence with the samples, and real-time upload of the detection results to Zhejiang Government service network for quick viewing and statistics, so as to complete the task of national nucleic acid screening efficiently and accurately that we must provide information support.

Protective effect and mechanism of saponins from Gleditsia sinensis on ischemic stroke with phlegm and blood stasis model rats / 中国药房

OB JECTIVE To study the protective effects of saponins from Gleditsia sinensis on ischemic stroke with phlegm and blood stasis （ISPBS）model rats ，and to explore its mechanism. METHODS Totally 119 rats were randomly divided into normal group （normal saline ），sham operation group （normal saline ），model group （normal saline ），nimodipine group （positive control group ，5 mg/kg），G. sinensis saponin low-dose ，medium-dose and high-dose groups （3.21，6.42 and 12.84 mg/kg），with 17 rats in each group. Except for normal group ，other groups were all given high-fat diet+suture-occluded method to induce ISPBS model. The neurological function score ，water content of brain tissue ，pathological morphology of brain tissue ，the changes of hemorheology indexes （whole blood viscosity ， erythrocyte aggregation index ， Casson-viscosity）， four items of blood lipid [triacylglycerol （TG），total cholesterol （TC），low-density lipoprotein cholesterol （LDL-C），high-density lipoprotein cholesterol（HDL-C）] and inflammatory factors in serum and oxidative stress indexes [malondialdehyde （MDA），nitric oxide （NO），superoxide dismutase （SOD）] in brain tissue were determined or observed in rats. The protein expressions of B lymphocytoma 2（Bcl-2），Bcl-2 associated X protein （Bax）and caspase- 3 in cerebral tissue were also detected. RESULTS Compared with normal group ，the score of nerve function ，5 kinds of serum indexes （TC，TG，LDL-C，TNF-α，IL-1β）， hemorheology indexes ，the contents of MDA and NO and protein expressions of Bax and caspase- 3 in cerebral tissue were all increased significantly in model group （P＜0.01）. The levels of HDL-C and IL- 10 in serum ，SOD activity and protein expression of Bcl- 2 in cerebral tissue were decreased significantly （P＜0.01），and obvious lesions such as nuclear pyknosis and cell membrane fragmentation occurred in brain tissue. Compared with model group ，above indexes of administration groups were improved to different extents ，among which there was statistical significance in above indexes of G. sinensis saponin high-dose group （P＜ 0.01）. CONCLUSIONS Saponin from G. sinensis has a good protective effect on ISPBS model rats. Its mechanism may beassociated with reducing oxidative damage ， reducing the production of pro-inflammatory mediators and resisting neuronal apoptosis.

Chinese Medicine Shensong Yangxin Capsule () Ameliorates Myocardial Microcirculation Dysfunction in Rabbits with Chronic Myocardial Infarction / 中国结合医学杂志

OBJECTIVE@#To investigate the effect of Chinese compound Shensong Yangxin Capsule ( , SSYX) on myocardial microcirculation in myocardial-infarcted rabbits.@*METHODS@#Myocardial infarction (MI) was established in rabbits by ligation of the left circumflex coronary. Thirty rabbits were randomly divided into the control group, the MI group (model), and the MI treated with SSYX group (MI+SSYX) by a random number table method. After 4 weeks of administration, low-energy real-time myocardial contrast echocardiography (RT-MCE) was conducted to assess the microcirculatory perfusion. Immunofluorescence double staining was used to detect the capillary density. The endothelial ultrastructure was observed with a transmission electron microscope. The mRNA expression levels of vascular endothelial growth factor (VEGF), endothelin 1 (ET-1), prostaglandin I2 (PGI2) and endothelial nitric oxide synthase (eNOS) were measured by real-time quantitative polymerase chain reaction (Real-time PCR). The plasmic levels of ET-1, thromboxane A2 (TXA2), nitric oxide (NO) and von willebrand factor (vWF) were examined with enzyme-linked immunosorbent assays (ELISA).@*RESULTS@#SSYX significantly improved the myocardial blood volume, myocardial micro bubble velocity, and myocardial inflow according to the examination of RT-MCE, and it visibly ameliorated the capillary endothelial structure. Furthermore, compared with the MI group, the plasma levels of TXA2, ET-1 and vWF contents significantly decreased in the MI+SSYX group, and the ET-1 mRNA expression levels of myocardium in the border zone significantly decreased, and the VEGF, PGI2 and eNOS mRNA expression levels significantly increased (all P<0.05).@*CONCLUSIONS@#SSYX has favorable advantages in ameliorating the impaired myocardial microcirculation following MI. The mechanisms of the effect are related to the ability of SSYX in balancing the endothelial-derived vasodilators and vasoconstrictors, and up-regulating the expression of VEGF and eNOS.

In situ intestinal absorption and pharmacokinetic study of metformin-resveratrol compound water-in-oil nanoemulsion / 中国药科大学学报

@#To investigate the in situ intestinal absorption characteristics and pharmacokinetic behavior of metformin-resveratrol compound water-in-oil nanoemulsion (MRCE) in rats, the in situ intestinal perfusion model was constructed in rats to study the intestinal absorption characteristics of MRCE in different intestinal segments. Male Sprague-Dawley rats were randomly divided into two groups. After intragastric administration of metformin and MRCE, blood was taken at a preset time point. The content of metformin in intestinal perfusion samples and blood samples at various time points was determined by HPLC. Plasma concentration-time profiles of free metformin and MRCE were calculated, and the main pharmacokinetic data were processed and analyzed by DAS 2.1.1 software. The absorption rate constant (Ka), the effective permeability (Peff) and the percentage of absorption (PA) of MRCE in each intestinal segment were significantly higher than those of metformin (P < 0.05). The area under the drug-time curve (AUC0-72 h), the half-life (t1/2) and mean residence time (MRT0-72 h) of MRCE were 1.68, 11.25 and 6.97 times of metformin, respectively (P < 0.01).The relative bioavailability of MRCE was 167.6%. The 90% confidence interval of AUC0-72 h was 156.9%-187.4%, which was not within the standard interval of bioequivalence. The intestinal absorption of MRCE was significantly better than that of free metformin; MRCE improved the oral bioavailability of metformin and was not bioequivalent to metformin.